Medical fluids intended for parenteral administration to a patient are typically supplied in solid containers such as vials and infusion bottles, or in collapsible bags, for example IV bags. At present these containers typically come with universally standardised necks and closure systems that conform to DIN standards. These containers are typically accessed either by hypodermic needles or spikes fitted to administration equipment in order to allow passage and administration of the fluid contained within. Medical fluids include medical suspensions and solutions, and biological liquids such as blood and plasma.
Products intended for parenteral administration may be intended for administration to different parts of the body and to different circulatory systems within the body. For example, some products and fluids are intended for intravenous delivery into the patient's blood system, whereas other products and fluids are intended for delivery to spinal fluids. It is extremely dangerous to administer products to the wrong system and, unfortunately, a number of patient fatalities have occurred as a consequence of the erroneous delivery of an epidural product to the blood system, and vice versa.
At present, health care professionals tend to rely on visual cues to ensure that a particular product is not administered incorrectly. However, it may be difficult in many situations for a health professional to track fluid tubing or conduits to confirm the route of entry into the body; especially where a patient is immobilised and those routes of entry are hidden beneath the patient.
Considerable work has been undertaken to differentiate the equipment and administration sets for the epidural administration of products from equipment and administration sets for intravenous administration of products. However, such work has focused on the architecture of the equipment and the administration sets downstream of the connector used to connect to the product. Because there is no differentiation between containers of epidural products and intravenous products, and because there is no differentiation of the connector on the equipment and administration set to connect to the product, the risk of a potentially fatal cross-over remains at the product container-connector interface.
It is the aim of the invention to provide a connector or connector system for medical fluid administration that can be readily incorporated into the seals of standard product containers such that containers holding fluids intended for a specified route of delivery may be physically differentiated from containers holding other fluids that are incompatible with that route of delivery. For example, it is an aim that containers containing fluids for epidural administration are physically incapable of connection to any current universal administration sets and apparatus for delivery of intravenous fluids.